Within three months of the U.S. Food and Drug Administration’s approval of mFLUSIVA, Moderna’s new mRNA flu vaccine, federal health officials received dozens of adverse event reports, including reports of serious medical events that some experts say raise safety concerns.
An analysis of the Vaccine Adverse Event Reporting System (VAERS) database, managed jointly by the FDA and Centers for Disease Control and Prevention (CDC), identified 78 reports involving mFLUSIVA in September and October.
The data, accurate as of Oct. 30, show that two reports were formally classified as serious, while several others described potentially significant medical problems.
Two reports described people who temporarily lost the ability to walk. One, a 71-year-old man, was flagged for a disability less than a day after vaccination when he experienced shaking arms and leg weakness that left him unable to walk.
In another report, an 84-year-old woman temporarily lost the ability to walk within an hour of vaccination. The woman reported severe weakness and being unable to stand, but the report was not formally classified as serious.
Her initial VAERS report listed her as age 71, but an updated version of the report in VAERS’ raw dataset lists her age as 84.
Other reports described a patient of unknown age hospitalized with fever and low oxygen levels, and a 76-year-old man who reported hallucinations after receiving mFLUSIVA and Moderna’s Spikevax COVID-19 shot.
“There are an alarming number of severe systemic reactions, including high fevers, debilitating fatigue and severe body aches and exhaustion” and a “highly concerning” number of cardiovascular adverse reactions,” said internal medicine physician Dr. Clayton J. Baker.
“This suggests significant systemic toxicity very much akin to the disease the shot is supposedly designed to prevent,” Baker said.
An analysis by The Defender found that, among 58 reports that included information on when symptoms began, 51 indicated that the reactions appeared on the day of vaccination or the following day. Baker said that “from a temporal standpoint, this strongly implicates the shots” as the likely cause of those injuries.
The Defender’s analysis also showed that 37 of the 78 reports noted that the individual received a COVID-19 vaccine around the same time they received Moderna’s mFLUSIVA shot.
Of those, 30 reports indicated that both shots were administered on the same day, while seven described vaccinations on different dates. Two reports also listed an RSV vaccine.
